ID

8596

Beschreibung

Eligibility Form for Protocol #040 - PR4001 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE1F242-913A-4391-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE1F242-913A-4391-E034-0003BA12F5E7

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Sarcoma, Kaposi xxx Eligibility - Eligibility Form for Protocol #040 - PR4001 - 2266387v3.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: Eligibility Form for Protocol #040 - PR4001
    1. No Instruction available.
Ccrr Module For Eligibility Form For Protocol #040 - Pr4001
Beschreibung

Ccrr Module For Eligibility Form For Protocol #040 - Pr4001

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Study#
Beschreibung

Protocol ID Coordinating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Site#
Beschreibung

NCIInstitutionIdentifierCode

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
ID#
Beschreibung

Patient Study ID

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Visit Date
Beschreibung

Dateofassessment

Datentyp

text

Does the patient have biopsy proven KS involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs?
Beschreibung

DoesthepatienthavebiopsyprovenKSinvolvingtheskin,lymphnodes,oralcavity,gastrointestinal(GI)tractand/orlungs?

Datentyp

boolean

Does the patient have Serologic documentation of HIV infection 21 days prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test?
Beschreibung

DoesthepatienthaveSerologicdocumentationofHIVinfection21dayspriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?

Datentyp

boolean

Is patient's baseline Karnofsky performance status >60%?
Beschreibung

Ispatient'sbaselineKarnofskyperformancestatus>60%?

Datentyp

boolean

Is patient's hemoglobin > 8 g/dl within 7 days of study entry?
Beschreibung

Ispatient'shemoglobin>8g/dlwithin7daysofstudyentry?

Datentyp

boolean

Is patient's absolute neutrophil count > 1500 cells/mm3 and platelets > 100,000 cells/mm3 within 7 days of study entry?
Beschreibung

Ispatient'sabsoluteneutrophilcount>1500cells/mm3andplatelets>100,000cells/mm3within7daysofstudyentry?

Datentyp

boolean

Is patient's creatinine < 1.5 times the upper limit of normal within 7 days of study entry?
Beschreibung

Ispatient'screatinine<1.5timestheupperlimitofnormalwithin7daysofstudyentry?

Datentyp

boolean

Is patient's total bilirubin <1.5x ULN within 7 days of study entry?
Beschreibung

Ispatient'stotalbilirubin<1.5xULNwithin7daysofstudyentry?

Datentyp

boolean

Is patient's AST (SGOT) and ALT (SGPT) < 3 x the upper limit of normal within 7 days of study entry?
Beschreibung

Ispatient'sAST(SGOT)andALT(SGPT)<3xtheupperlimitofnormalwithin7daysofstudyentry?

Datentyp

boolean

Is patient's life expectancy > 3 months?
Beschreibung

Ispatient'slifeexpectancy>3months?

Datentyp

boolean

Is the patient age of 18 or older?
Beschreibung

Isthepatientageof18orolder?

Datentyp

boolean

Does the patient have ability and willingness to give informed consent?
Beschreibung

Doesthepatienthaveabilityandwillingnesstogiveinformedconsent?

Datentyp

boolean

If female capable of childbearing, has the patient had a negative serum B-HCG within 72 hours prior to study entry?
Beschreibung

Iffemalecapableofchildbearing,hasthepatienthadanegativeserumB-HCGwithin72hourspriortostudyentry?

Datentyp

text

If female capable of childbearing, does the patient agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
Beschreibung

Iffemalecapableofchildbearing,doesthepatientagreetopracticeadequatebirthcontroltopreventpregnancywhilereceivingtreatmentandforthreemonthsaftertreatmentisdiscontinued?

Datentyp

text

If female, is the patient breast feeding?
Beschreibung

Iffemale,isthepatientbreastfeeding?

Datentyp

text

If male of child fathering potential, does the patient agree to practice adequate birth control?
Beschreibung

Ifmaleofchildfatheringpotential,doesthepatientagreetopracticeadequatebirthcontrol?

Datentyp

text

In the opinion of the investigator, is the patient capable of complying with the protocol?
Beschreibung

Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththeprotocol?

Datentyp

boolean

If patient is receiving antiretroviral therapy, is the patient on a stable regimen for at least 4 weeks prior to study entry?
Beschreibung

Ifpatientisreceivingantiretroviraltherapy,isthepatientonastableregimenforatleast4weekspriortostudyentry?

Datentyp

boolean

Does the patient have concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
Beschreibung

Doesthepatienthaveconcurrent,acute,activeopportunisticinfectionotherthanoralthrushorgenitalherpeswithin14daysofenrollment?

Datentyp

boolean

Does the patient have symptomatic visceral Kaposi's Sarcoma requiring cytotoxic therapy unless the patient has already been shown to be refractory to or intolerant of all currently approved agents for visceral Kaposi's Sarcoma?
Beschreibung

DoesthepatienthavesymptomaticvisceralKaposi'sSarcomarequiringcytotoxictherapyunlessthepatienthasalreadybeenshowntoberefractorytoorintolerantofallcurrentlyapprovedagentsforvisceralKaposi'sSarcoma?

Datentyp

boolean

Does the patient have concurrent neoplasia requiring cytotoxic therapy?
Beschreibung

Doesthepatienthaveconcurrentneoplasiarequiringcytotoxictherapy?

Datentyp

boolean

Has the patient had acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of study entry?
Beschreibung

Hasthepatienthadacutetreatmentforaninfection(otherthanoralthrushorgenitalherpes)orotherseriousmedicalillnesswithin14daysofstudyentry?

Datentyp

boolean

Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
Beschreibung

Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma(includingchemotherapy,radiationtherapy,localtherapy,biologicaltherapy,orinvestigationaltherapy)withintwoweeksofstudyentry?

Datentyp

boolean

Has the patient had previous local therapy of any KS-indicator lesion within 60 days unless the lesion has clearly progressed since treatment?
Beschreibung

HasthepatienthadpreviouslocaltherapyofanyKS-indicatorlesionwithin60daysunlessthelesionhasclearlyprogressedsincetreatment?

Datentyp

boolean

Has the patient used of investigational drugs other than IND-available anti-retroviral agents?
Beschreibung

HasthepatientusedofinvestigationaldrugsotherthanIND-availableanti-retroviralagents?

Datentyp

boolean

Does the patient have evidence of a prior MI or cardiac ischemia?
Beschreibung

DoesthepatienthaveevidenceofapriorMIorcardiacischemia?

Datentyp

boolean

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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Eligibility Form for Protocol #040 - PR4001
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Ccrr Module For Eligibility Form For Protocol #040 - Pr4001
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol ID Coordinating Group
Item
Study#
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
NCIInstitutionIdentifierCode
Item
Site#
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)
Patient Study ID
Item
ID#
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Dateofassessment
Item
Visit Date
text
DoesthepatienthavebiopsyprovenKSinvolvingtheskin,lymphnodes,oralcavity,gastrointestinal(GI)tractand/orlungs?
Item
Does the patient have biopsy proven KS involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs?
boolean
DoesthepatienthaveSerologicdocumentationofHIVinfection21dayspriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?
Item
Does the patient have Serologic documentation of HIV infection 21 days prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test?
boolean
Ispatient'sbaselineKarnofskyperformancestatus>60%?
Item
Is patient's baseline Karnofsky performance status >60%?
boolean
Ispatient'shemoglobin>8g/dlwithin7daysofstudyentry?
Item
Is patient's hemoglobin > 8 g/dl within 7 days of study entry?
boolean
Ispatient'sabsoluteneutrophilcount>1500cells/mm3andplatelets>100,000cells/mm3within7daysofstudyentry?
Item
Is patient's absolute neutrophil count > 1500 cells/mm3 and platelets > 100,000 cells/mm3 within 7 days of study entry?
boolean
Ispatient'screatinine<1.5timestheupperlimitofnormalwithin7daysofstudyentry?
Item
Is patient's creatinine < 1.5 times the upper limit of normal within 7 days of study entry?
boolean
Ispatient'stotalbilirubin<1.5xULNwithin7daysofstudyentry?
Item
Is patient's total bilirubin <1.5x ULN within 7 days of study entry?
boolean
Ispatient'sAST(SGOT)andALT(SGPT)<3xtheupperlimitofnormalwithin7daysofstudyentry?
Item
Is patient's AST (SGOT) and ALT (SGPT) < 3 x the upper limit of normal within 7 days of study entry?
boolean
Ispatient'slifeexpectancy>3months?
Item
Is patient's life expectancy > 3 months?
boolean
Isthepatientageof18orolder?
Item
Is the patient age of 18 or older?
boolean
Doesthepatienthaveabilityandwillingnesstogiveinformedconsent?
Item
Does the patient have ability and willingness to give informed consent?
boolean
Item
If female capable of childbearing, has the patient had a negative serum B-HCG within 72 hours prior to study entry?
text
CL.12
Code List
If female capable of childbearing, has the patient had a negative serum B-HCG within 72 hours prior to study entry?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
If female capable of childbearing, does the patient agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
text
CL.13
Code List
If female capable of childbearing, does the patient agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
If female, is the patient breast feeding?
text
CL.14
Code List
If female, is the patient breast feeding?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
If male of child fathering potential, does the patient agree to practice adequate birth control?
text
CL.15
Code List
If male of child fathering potential, does the patient agree to practice adequate birth control?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththeprotocol?
Item
In the opinion of the investigator, is the patient capable of complying with the protocol?
boolean
Ifpatientisreceivingantiretroviraltherapy,isthepatientonastableregimenforatleast4weekspriortostudyentry?
Item
If patient is receiving antiretroviral therapy, is the patient on a stable regimen for at least 4 weeks prior to study entry?
boolean
Doesthepatienthaveconcurrent,acute,activeopportunisticinfectionotherthanoralthrushorgenitalherpeswithin14daysofenrollment?
Item
Does the patient have concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
boolean
DoesthepatienthavesymptomaticvisceralKaposi'sSarcomarequiringcytotoxictherapyunlessthepatienthasalreadybeenshowntoberefractorytoorintolerantofallcurrentlyapprovedagentsforvisceralKaposi'sSarcoma?
Item
Does the patient have symptomatic visceral Kaposi's Sarcoma requiring cytotoxic therapy unless the patient has already been shown to be refractory to or intolerant of all currently approved agents for visceral Kaposi's Sarcoma?
boolean
Doesthepatienthaveconcurrentneoplasiarequiringcytotoxictherapy?
Item
Does the patient have concurrent neoplasia requiring cytotoxic therapy?
boolean
Hasthepatienthadacutetreatmentforaninfection(otherthanoralthrushorgenitalherpes)orotherseriousmedicalillnesswithin14daysofstudyentry?
Item
Has the patient had acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of study entry?
boolean
Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma(includingchemotherapy,radiationtherapy,localtherapy,biologicaltherapy,orinvestigationaltherapy)withintwoweeksofstudyentry?
Item
Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
boolean
HasthepatienthadpreviouslocaltherapyofanyKS-indicatorlesionwithin60daysunlessthelesionhasclearlyprogressedsincetreatment?
Item
Has the patient had previous local therapy of any KS-indicator lesion within 60 days unless the lesion has clearly progressed since treatment?
boolean
HasthepatientusedofinvestigationaldrugsotherthanIND-availableanti-retroviralagents?
Item
Has the patient used of investigational drugs other than IND-available anti-retroviral agents?
boolean
DoesthepatienthaveevidenceofapriorMIorcardiacischemia?
Item
Does the patient have evidence of a prior MI or cardiac ischemia?
boolean
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